BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIST¿

    MDR report key: 12786421 · Received November 10, 2021

    Report

    Report Number
    12786421
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 3, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A RIST¿ 95 CM RADIAL ACCESS GUIDE SHEATH WAS RETAINED INSIDE THE PATIENT. VASCULAR SURGERY WAS NEEDED TO REMOVE THE RETAINED VASCULAR GUIDE-CATHETER. FROM THE PATIENT'S CHART, "PATIENT WAS DISCHARGE (D/C). 49F WITH ABORTED ANEURYSM EMBOLIZATION, COMPLICATED BY (C/B) RETAINED RADIAL CATHETER, REQUIRING OPEN SURGICAL INTERVENTION DOING WELL THIS MORNING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684009 RIST¿ CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. 107F-079-95 17369-01

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA Female Other| R